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Appendix H: Evidence tables


              Bibliographic details   Study type &   Patient characteristics   Test, Reference Standard,   Results                Reviewers Comments
                                Evidence level                            Threshold for a positive test
              France, Italy,                 GA: > 36 week = 80.2%                                 Sternum
              Switzerland)                   Postnatal age: < 48 hours = 16.3%   Blood sample also collected for   r = 0.85, P < 0.001
                                             Gender: Not reported         TSB estimation using HPLC-B
              77                                                          technique at the same time   Correlation of lab TSB levels with TSB
                                             Ethnicity                                             levels using HPLC-B
                                             White = 66.7%                Diagnostic accuracy of TcB   (Pearson correlation coefficient, n = 210)
                                             Asian = 14.8%                (various thresholds) estimated at
                                             Hispanic = 6.7%              various thresholds and plotted on   r = 0.93, P < 0.001
                                             Other = 11.9%                ROC curve.
                                                                                                   Bland Altman analysis for difference
                                             Exclusion: not defined                                between lab TSB and TcB

                                                                                                   Forehead
                                                                                                   MD = +2.4 micromol/litre (95% CI -2.4 to
                                                                                                   +7.1)
                                                                                                   SD = 35.4 micromol/litre

                                                                                                   Sternum
                                                                                                   MD = -14.8 micromol/litre (95% CI -19.9 to
                                                                                                   +9.5)
                                                                                                   SD = 38.4 micromol/litre

                                                                                                   Diagnostic accuracy of TcB on forehead
                                                                                                   (threshold 187 micromol/litre) for detecting
                                                                                                   TSB > 222 micromol/litre by HLPC-B

                                                                                                   Sensitivity: 93%
                                                                                                   Specificity: 73%

                                                                                                   Diagnostic accuracy of TcB (threshold
                                                                                                   238 micromol/litre) for detecting TSB >
                                                                                                   290 micromol/litre by HLPC-B

                                                                                                   Sensitivity: 90%
                                                                                                   Specificity: 87%


              Boo NY;           Study Type:   Healthy term Malaysian babies with   TcB using BiliChek from the   Correlation of TcB levels with lab TSB   Unselected population
                                Diagnostic study   hyperbilirubinaemia    forehead and midpoint of sternum –   levels (Pearson correlation coefficient,   Test & Reference test described
              Year: 2007                                                  number of measurements from each   n = 345)             adequately
                                Evidence Level:   n = 345                 site not specified                                      Test and reference test carried
              Country:          Ib           mean BW: 3056 ± 487 g,                                Forehead                       out within one hour
              Malaysia                       median GA 38 weeks           Reference standard: Laboratory   All babies             Blinding – yes
                                                                          TSB levels within 30 minutes of   r = 0.80, P < 0.0001   Data not given for the mean
              78                             postnatal age: range 9 – 388   TcB measurement        Malays: r = 0.79, P < 0.0001   difference and SD from Bland
                                             Gender: Males = 60%                                   Chinese: r = 0.84, P < 0.0001   Altman analysis for TSB – TcB

                                             Ethnicity                    Diagnostic accuracy of TcB   Indians: r = 0.83, P < 0.0001
                                             Malays = 63.8%               (various thresholds) calculated for


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